Torax Medical recalls LINX Reflux Management System implants with possible bead separation causing device discontinuity. Affected units include specific product codes and lot numbers. Consumers should contact for details.
Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
Torax Medical is recalling LINX Reflux Management System implants that may have a bead component separating from the wire link, potentially causing the device to become open or discontinuous. This could lead to improper function of the device, which is intended to treat severe GERD.
The device may have a bead component that separates from the wire link, causing the LINX device to become discontinuous or open. This could lead to improper function of the implant, which is designed to manage gastroesophageal reflux disease (GERD).
Patients who received the LINX Reflux Management System implant for severe GERD, as defined by abnormal pH testing and needing an alternative to acid suppression therapy. Those with specific product codes (LXM-13 to LXM-16) and lot numbers listed are most at risk.
Check if your LINX Reflux Management System implant has product codes LXM-13, LXM-14, LXM-15, or LXM-16 with lot numbers 6100 through 14055, 15286, 15287, 15314, 15315, 15317, or 16557.
Identify your product code (LXM-13 to LXM-16) and lot number to confirm if it is affected.
The LINX Reflux Management System is a laparoscopic, fundic-sparing anti-reflux procedure for patients diagnosed with Gastroesophageal Reflux Disease (GERD) who need an alternative to continuous acid suppression therapy.
Product codes LXM-13, LXM-14, LXM-15, and LXM-16 with specific lot numbers (6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557) are affected.
The recall does not specify a remedy, so contact Torax Medical directly for further instructions.
We’ve drafted a message you can send Torax Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2041-2018 — Torax Medical Torax Medical Hello, I own a Torax Medical that is covered by recall Z-2041-2018 from Torax Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
